Stem Recruitment have a fantastic opportunity for a Quality Engineer to work for an IVD company based near Edinburgh. This person will be responsible for the management of Complaints, Post Market Surveillance (PMS) and Product Risk Management for all their Products.
Responsibilities
- Ensure the complaint management process for all products is completed to a high standard in compliance with internal procedures and international standards.
- Through completion of the relevant Product Risk Management and Product Post Market Surveillance (PMS) activities, ensure that their products are maintained in compliance with all relevant Regulations.
- Manage risk throughout the entire Design Control Process for new projects and through Core QMS processes (such as Non-Conforming Product management, Change Management, Complaint Management) for on market products.
Requirements
Science degree or equivalent qualification, or a relevant degree combined with appropriate industry experience.
Experience in medical device/IVD/Biotech industry
Strong understanding of QMS processes, i.e. Customer Complaints, CAPA, change management
If this role is of interest, please get in touch.